35.11 - Biohazard Safety

May 20, 2010 (rewrite)

A. General. The proper management of biological agents and the vectors that may harbor these agents, is important in providing the necessary protection for employees, students and the environment. Any use, possession, storage, or transfer of biological agents requires approval from the Institutional Biosafety Committee (see FSH 1640.14) and the Office of Research and Economic Development. In addition, federal or state approval may be required when conducting research activities using Select Agents and Toxins, when releasing genetically modified organisms or biological agents to the environment, or when transferring biological agents to another person or facility. [ed. 5-11]

B. Definitions.

B-1. Biological agents - Any bacteria, recombinant DNA, fungi, transgenic organisms, viruses, rickettsiae, chlamydiae, parasites, allergens, viroids, virions, and prions that can be harmful to humans, livestock, plants, or the environment or that have been genetically modified.

C. Procedure. The Institutional Biosafety Committee approves all activities involving biological agents (listed below) and also serves as a resource for providing information on biohazard safety and management of infectious materials:

Recombinant DNA activities;

Activity involving the cultivation of production of genetically modified organisms;

Activity involving the release or cultivation of genetically modified organisms or biological agents in the environment (exception for USDA deregulated items);

Any use, possession, storage, or transfer of Select Agents and Toxins;

Any activity involving the use, possession, storage, or transfer of any biological agent; and

Research activities involving known infectious tissues/materials, [which includes established human cell lines that present human hazards and as such are classified as Risk Group 2 (RG2) agents (BSL2)], substances/specimens containing infectious materials that include activities that either propagate these materials, (e.g. growth of microbiological specimens) or potentially expose workers to these agents, e.g. sifting of soil samples (aerosolizing the soil) when the soil is known to contain an infectious agent or is from a region where there are infectious agents endemic in the soil, e.g. Bacillus anthracis is endemic in parts of the Southwest in the United States.

C-1. Memorandum of Understanding and Agreement. Any investigator working with the material listed above must complete a Biosafety Memorandum of Understanding and Agreement (MUA) application found at

Submit the completed MUA application to the Office of Research Assurances.

C-2. Biosafety Manual and Facility Review. The investigator must complete a biosafety manual and facility review that addresses laboratory and research safety procedures, such as proper personal protective equipment, appropriate research equipment (autoclaves, biosafety cabinets, chemical fume hoods, etc.), signage, easy access to safety information such as Material Safety Data Sheets (MSDSs), and the ability to manage different wastes (biological, hazardous chemical, sharps, etc.). A template for a biosafety manual and a facility review checklist may be obtained from the Biosafety Officer in Environmental Health and Safety Office (EHSO) and/or the Office of Research Assurances (ORA) see F below.

C-3. MUA Renewal. An approved MUA is valid for three years. If the investigator plans to continue project work beyond the three years it is the responsibility of the investigator to obtain renewal before the end of the three years.

C-4. MUA Amendment. An MUA must be amended any time there is a change in the approved use. Changes include, but are not limited to, a change in protocols, a change in location of use, a change in type of material, or a change in personnel. Amendments may be submitted to the Biosafety Officer or to ORA in an email explaining all protocol changes.

C-5.Documentation. A copy of the approved MUA, along with associated documentation on research protocols and training of lab personnel must be kept on file with the investigator.

D. Information on Specific Federal Agencies. Receipt of a grant or approval from a federal agency does not relieve the investigator from obtaining a university MUA prior to conducting any of the above activities.

D-1.Federal Agencies: Guidelines specific to the below mentioned agencies can be found off the ORA website or their respective websites.

a. National Institutes of Health (NIH). Funding from NIH, specifically for recombinant DNA activities, requires investigators to follow the "NIH Guidelines for Research Involving Recombinant DNA Molecules" found at the Office of Biotechnology Activities off the NIH website.

b. USDA Animal and Plant Heath Inspection Service (APHIS).

c.Select Agents and Toxins. The use, possession, storage, and transfer of Select Agents and Toxins is regulated by the Centers for Disease Control and Prevention (CDC) or APHIS. A list of Select Agents and Toxins can be found at the CDC, APHIS or NSAR websites.

An investigator must register with the CDC or APHIS to use Select Agents and Toxins. To begin the registration process contact the University Research Office at (208) 885-4989.

E. Educational Opportunities. In addition to the below educational opportunities, other opportunities are available through EHSO and ORA, see F below.